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Can a drug shrink nasal polyps in rare disease patients?

NCT ID NCT07592104

Symptom relief Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 52 adults with EGPA (a rare inflammatory disease) and severe chronic sinusitis with nasal polyps. They received mepolizumab 300 mg every 4 weeks. The goal was to see if the drug reduces polyp size and improves symptoms like nasal congestion and sense of smell over 12 months. The study was observational, meaning researchers watched what happened in real-life medical practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mepolizumab 300 mg
What this could lead to
If successful, this could show that mepolizumab helps shrink nasal polyps and improve breathing and quality of life for people with EGPA and chronic sinusitis.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It is also small (52 people) and completed, so findings may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

52 people

The number who actually took part.

Started

Sep 2025

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

We will collect data from patients affected by EGPA and concomitant severe chronic rhinosinusitis with nasal polyps (CRSwNP) not controlled by local and systemic corticosteroids and/or surgery, who have received indication, during normal clinical practice, to therapy with Mepolizumab 300mg every 4 weeks (self-administered at home with subcutaneous autoinjector), in addition to topical nasal corticosteroids. For the retrospective cohort, the start of observation is from 01 March 2023 We be enrolled 52 patients.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria Eligible patients will be: * Patients over 18 years of age who can sign a written informed consent; * Confirmed diagnosis of EGPA by rheumatologist and in treatment with Mepolizumab 300 mg every 4 weeks, according to clinical pratice; * Confirmed clinical / radiological diagnosis of chronic rhinosinusitis with diffuse naso-sinusal polyposis by nasal endoscopy and/or massive facial CT scan without contrast medium carried out within 6 months prior to the start of therapy; * Severe disease stage, defined by Nasal Polyp Score (NPS) ≥ 5 or nasal obstruction symptom visual analogue scale (VAS) score of \>5 and/or SNOT-22 ≥ 50); * Inadequate symptom control with intranasal local corticosteroid therapy; * Failure of previous medical treatments (at least 2 cycles in the last year of systemic corticosteroid) or failure of previous surgical treatment through nasal endoscopic surgery (FESS), with no clinical benefit or postoperative complications. Exclusion criteria * Age \<18 years; * Patients with EGPA with organ impairment or at risk of death; * Patients undergoing radio/chemotherapy treatments for cancer in the 12 months before the start of therapy.

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Conditions

The condition(s) this trial relates to.

chronic rhinosinusitis eosinophilic granulomatosis with polyangiitis paranasal sinus disorder sinusitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic rhinosinusitis (CRS) with and without nasal polyps Egpa - eosinophilic granulomatosis with polyangiitis Sinus disease

Contacts and locations

Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, Roma, 00168, Italy

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